Aranesp Fails in RED-HF Trial

The RED-HF trial, testing darbepoetin alfa (Aranesp) in heart failure patients with anemia, failed to meet its primary endpoint, according to top-line results released by Amgen.

The phase III trial results showed no difference between the treatment and placebo arms in the composite endpoint of time to death from any cause or first hospital admission for worsening heart failure (HR 1.01, 95% CI 0.90 to 1.13).

Darbepoetin is indicated for the treatment of anemia due to chronic kidney disease in patients on dialysis and not on dialysis (approved in 2001), and in certain cancer patients where anemia is due to the effect of chemotherapy (approved in 2002).

In June of 2011, the FDA urged tailored dosing for erythropoiesis-stimulating agents (ESAs) such as darbepoetin alfa and epoetin alfa (Epogen, Procrit) in chronic kidney disease patients because of an increased risk of cardiovascular events.

The agency added new language to the labels of these drugs asking physicians and patients to "weigh the possible benefits of using ESAs to decrease the need for red blood cell transfusions against the increased risks for serious adverse cardiovascular events."

The FDA's action was prompted by data from the TREAT (Trial to Reduce Cardiovascular Events With Aranesp Therapy) study that showed an increased risk of stroke for diabetic patients with chronic kidney disease who were not yet on dialysis and were taking darbepoetin (HR 1.92).

The RED-HF (Reduction of Events With Darbepoetin Alfa in Heart Failure) trial was initiated in 2006 and enrolled 2,278 patients with symptomatic systolic heart failure and anemia. Patients were randomized 1:1 to the study drug or placebo.

The target hemoglobin for patients in the darbepoetin arm was 13.0 g/dL (not to exceed 14.5 g/dL).

Amgen also reported that no new safety findings were identified in the study. The most frequently reported adverse events in the study were cardiac failure, dyspnea, diarrhea, congestive heart failure, and dizziness.

The company said it planned to do a full safety and efficacy analysis of the results and submit them for presentation at a medical meeting, but did not announce any other plans for the drug in anemic heart failure patients.

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